Cardiovascular Disease Clinical Trial
Official title:
SMDC Pacemaker-MRI Cohort Study
The purpose of this study is to monitor and follow non-pacemaker dependent patients with
implanted permanent pacemakers, who undergo medically required Magnetic Resonance Imaging
(MRI) scans.
Patients with pacemakers are currently excluded from obtaining MRI scans. MRI scanning is
now the imaging of choice for a number of neurological, vascular, or musculoskeletal
conditions.
Data suggests that patients with pacemakers, when properly monitored, can safely undergo MRI
scanning, though the largest published study to date consists of 54 patients, and no long
term follow-up has been published.
Though MRI cardiac scanning has been demonstrated to produce local tissue heating at the
pacemaker lead tip, the long term effect of tissue heating on lead stability is unclear.
This study will evaluate patients with permanent pacemakers undergoing medically indicated
MRI scanning.
Patients will be followed for one year at 3, 6, and 12 months. Data collected will evaluate
change in pacing thresholds over time as well as cardiac troponin I, creatinine kinase MB
function, and myoglobin levels within the first 12 hours following the scans, side effects,
symptoms, the need to make pacemaker program changes, and possible artifacts created by the
pacemaker on the MRI scan.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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